Results of the performance verification of the CoaguChek XS system

Plesch, Winfried; Wolf, Tanja; Breitenbeck, Nancy; Dikkeschei, L. D.; Cerveró, Alba Jover; Pérez, Pedro Luis Hernández; Besselaar, A.M.H.P. van den

doi:10.1016/j.thromres.2008.04.021

Cited by 66 publications

(70 citation statements)

References 7 publications

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“…The study was sponsored by Roche Diagnostics. 3 Spearman's coefficient for the correlation between INR values in the present study was very high at 0.97 with p<0.0001. Correlation coefficients greater than laboratories should be considered.…”

Section: Discussionmentioning

confidence: 38%

“…An earlier study reported a much lower error rate, just 1.5%. 3 We believe that the variation is due to the learning curve related to obtaining the blood sample, since this research project was the occasion of first contact with the equipment. It should be pointed out that, according to the manual, the manufacturer Roche Diagnostics offers a home visit by a trained professional for the purposes of instruction with each device purchased.…”

Section: Discussionmentioning

confidence: 99%

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Comparison between the conventional method and a portable device for determination of INR

2014

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Context: Anticoagulation with warfarin is considered the appropriate treatment for venous thromboembolism and other thrombotic pathologies. Regular INR control is required for dosage adjustment and therapeutic control. Use of portable monitoring systems optimizes management of these patients. Objective: To compare INR measurements taken using the portable Coaguchek XS system in capillary blood with the standard laboratory method using venous blood. Method: Fifty-two samples each of venous and capillary blood were collected from nineteen patients on warfarin, who had been admitted to the Hospital da Beneficência Portuguesa de São Paulo, and analyzed using the conventional method and the Coaguchek XS system, respectively. Results: Spearman' s correlation coefficient (r) for the overall performance of the two methods was 0. 978 (p<0.0001; Exclusion criteria. samples were excluded if problems affected biological material collection.Determination of PT by the conventional method. 10 mL venous blood samples were collected into tubes containing 3.8% sodium citrate solution. Plasma was extracted from the samples by centrifugation at 3,800 rpm for 5±2 minutes and then the PT with INR was assayed using an ACL Elite Pro automated coagulation analyzer and a kit containing thromboplastin Recombiplastin 2G solution with an International Sensitivity Index (ISI) of 1.0.Determination of PT using the portable test. Samples of capillary blood were taken within one hour of collection of samples for the conventional method. Samples of approximately 10 µL were taken by finger stick from the finger pad of the first finger of patients' non-dominant hand, using Accu-Chek Safe-T-Pro Uno lancets. The blood drop was placed onto a Coaguchek XS PT test strip containing human recombinant thromboplastin with an ISI of 1.0 and the device displayed the result in approximately one minute.Classification of samples. The results for the 52 samples were classified by therapeutic range: INR < 2.0; INR 2.0 -3.5; or INR > 3.5.Ethical approval. The research project was approved by the Research Ethics Committee at the Hospital da Beneficência Portuguesa de São Paulo and all patients indicated their agreement to participation by signing consent forms. Statistical analysisThe INR results provided by the two different methods were analyzed for the entire sample and for the three subsets: INR <2.0; INR 2.0-3.5; and INR >3.5. The following analyses were performed: Student's t test for paired samples, Spearman's correlation index and the BlandAltman test, for evaluation of the differences between results. A 95% confidence interval and an α error of p<0.05 for statistical significance were adopted. Microsoft Excel 2007 was used for statistical analysis with the XLSTAT (trial version) and Analyze-it add-ins.

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Section: Discussionmentioning

confidence: 38%

Section: Discussionmentioning

confidence: 99%

Comparison between the conventional method and a portable device for determination of INR

2014

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“…For the CoaguChek XS the analytical quality has been thoroughly documented, [10][11][12][13][14] and our finding that patient SDs are smaller than during conventional treatment emphasizes this. Thus, the analytical imprecision is unimportant in relation to patient variation.…”

Section: Discussionmentioning

confidence: 88%

Home Management of Oral Anticoagulation via Telemedicine Versus Conventional Hospital-Based Treatment

Christensen

Lauterlein

Sørensen

et al. 2011

Telemedicine and e-Health

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Background and Objective: We have developed an expert computer system for the control of oral anticoagulation therapy, accessible by the patients via their own computer. To investigate if the weekly measurement and dosing of international normalized ratio (INR) at home using the online Internet-based system was superior to conventional treatment, we performed a randomized, controlled trial. Patients and Methods: All 669 patients in our anticoagulation clinic were asked to participate in the trial, providing that they had Internet access and could use the CoaguChek XS system. A total of 140 patients were included and randomized to (A) once weekly measurement and report online, (B) twice weekly measurement and report online, and (C) continued conventional treatment with INR measurement in the lab every 4 weeks and dose adjustment by letter. Results: Group A had 79.7% (95% CI 79.0-80.3) of time in therapeutic range (TTR), group B 80.2% (95% CI 79.4-80.9) of TTR, and group C 72.7% (95% CI 71.9-73.4) TTR. Groups A and B perform statistically significantly better than the conventional group C, with a difference of TTR of 7% points (p < 2.2 · 10 À16 ), whereas

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“…Plesch et al had demonstrated before that there was no significant deviation between results from capillary with those from corresponding venous blood samples on the CoaguChek XS system [16]. This system has an integrated quality control function.…”

Section: Prothrombin Time and International Normalized Ratiomentioning

confidence: 99%

“…However, in non-APS patients, the precision of the CoaguChek XS system was found to be similar to that of laboratory PT assays. Whereas CVs obtained from two measurements have been shown to vary between 3.6 and 8.3 % with the use of a conventional PT assay [30], the INR measurements from the CoaguChek XS system revealed CVs of 2.0-3.2 % for venous blood samples and 2.9-4.0 % for capillary blood samples [16]. Moreover, self-management has been demonstrated to improve the quality of VKA therapy by increasing the amount of time within the therapeutic INR range (i.e.…”

Section: Inr Differences Between Different Pt Assaysmentioning

confidence: 99%

Monitoring anticoagulant therapy with vitamin K antagonists in patients with antiphospholipid syndrome

et al. 2015

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Because of the possible interference of antiphospholipid antibodies (APL) with the phospholipid component of thromboplastin reagents, concerns have been raised about the validity of international normalized ratio (INR) testing to monitor anticoagulant therapy with vitamin K antagonists in patients with antiphospholipid syndrome (APS). To investigate the reliability of the INR, we determined the INR using various prothrombin time (PT) assays and compared the results with those of a chromogenic factor X (CFX) assay. The study cohort consisted of 40 APS patients and 100 APL-negative patients who were on anticoagulant therapy for reasons other than APS. The agreement (i.e. the percentage of patients with a difference ≤0.5 INR units) between the PT-derived INR and CFX-derived INR equivalents was only moderate in both patient groups. The best agreement with CFX-derived INR equivalents was observed for the Thromborel S reagent in APS patients (69.1 %) and for Neoplastin Plus in APL-negative patients (72.0 %). Regarding the results for the point-of-care system CoaguChek XS, an agreement between the INR and the CFX-derived INR equivalent was less frequently observed in the APS patients (55.6 vs. 67.8 %; p = 0.050). When considering all 3058 pairs of INR tests within the international sensitivity index (ISI)-calibrated range of 1.5 to 4.5 s, we did not observe a higher variability of INR values in either the APS patient group or the subgroup of APS patients positive for lupus coagulants compared with the APL-negative controls. In conclusion, monitoring vitamin K antagonists (VKA) therapy with laboratory INR measurements seems to be suitable for the majority of APS patients.

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Results of the performance verification of the CoaguChek XS system

Cited by 66 publications

References 7 publications

Comparison between the conventional method and a portable device for determination of INR

Comparison between the conventional method and a portable device for determination of INR

Home Management of Oral Anticoagulation via Telemedicine Versus Conventional Hospital-Based Treatment

Monitoring anticoagulant therapy with vitamin K antagonists in patients with antiphospholipid syndrome

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